On 3 April 2020, the European Commission has adopted a proposal to postpone by one year the date of application of the Medical Devices Regulation to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic.
This decision takes into account the unprecedented challenges of the coronavirus pandemic and the need for an increased availability of vitally important medical devices across the EU whilst continuing to ensure patient health and safety until the new legislation becomes applicable.
As the coronavirus crisis increases demands for certain vital medical devices, it is crucial to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices caused by capacity limitations of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation.
The proposal therefore postpones the application of the Regulation by one year - until 26 May 2021.
Whilst the new Medical Devices Regulation is key to ensure patient safety and increase transparency on medical devices across the EU, the currently applicable rules will continue to guarantee the protection of public health.
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